# K120663: Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone Epi

- Pathway: 510(k) (Traditional)
- Applicant: Dako North America, Inc.
- Decided: Feb 12, 2013 after 344 days
- Product code: MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P880026 (1988). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042884: Dakocytomation ER/PR Pharmdx Kit, Dakocytomation California, Inc. (2005) Summary page 2.

## Most influential descendants
- K170028: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (2017), 0 descendants of its own
- K160922: FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (2016), 0 descendants of its own

## Indications for use
For in vitro diagnostic use. FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EPi, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVisionTh FLEX, High pH visualization kit together with Autostainer Link 48 to semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor α-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Source page: https://510kreport.com/device/K120663
Methodology: https://510kreport.com/methodology